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Cited by 23

Multi‐Angle Light Scattering as a Process Analytical Technology Measuring Real‐Time Molecular Weight for Downstream Process Control

Patel, Bhumit A., Gospodarek, Adrian, Larkin, Michael, Kenrick, Sophia A., Haverick, Mark A., Tugcu, Nihal, Brower, Mark A., Richardson, Douglas D.·2018·mAbs
DOI 10.1080/19420862.2018.1505178PMC PMC6204791
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  • MALS in an in-line setup during mAb purification monitored protein aggregation, leading to real-time results and immediate feedback control.

    “Its application in real‐time protein analytics was explored by using it in an in‐line setup during the mAb purification to monitor the protein aggregation, which led to real‐time results and immediate feedback control [106].”

    From Current PAT Landscape in the Downstream Processing of Biopharmaceuticals (2025) · cites this paper as [106]

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Research works printed but not linked: 19

  1. [1]Vazquez-Rey M, Lang DA. Aggregates in monoclonal antibody manufacturing processes. Biotechnol Bioeng. 2011; 108(7): 1494– 1508. 21480193
  2. [2]Cromwell ME, Hilario E, Jacobson F. Protein aggregation and bioprocessing. AAPS J. 2006; 8(3): E572– 9. doi: 10.1208/aapsj080366. 17025275 PMC2761064 · DOI
  3. [3]Mason BD, Schöneich C, Kerwin BA Effect of pH and light on aggregation and conformation of an IgG1 mAb. Mol Pharm. 2012; 9(4): 774– 790. doi: 10.1021/mp2004719. 22300012 · DOI
  4. [4]Moussa EM, Panchal JP, Moorthy BS, Blum JS, Joubert MK, Narhi LO, Topp EM Immunogenicity of therapeutic protein aggregates. J Pharm Sci. 2016; 105(2): 417– 430. doi: 10.1016/j.xphs.2015.11.002. 26869409 · DOI
  5. [5]Rosenberg AS Effects of protein aggregates: an immunologic perspective. AAPS J. 2006; 8(3): E501– E507. doi: 10.1208/aapsj080359. 17025268 PMC2761057 · DOI · Paper page
  6. [6]Evans W Removing aggregates in monoclonal antibody purification. Pharm Technol. 2015; 39(3): 72– 74.
  7. [7]Liu HF, Ma J, Winter C, Bayer R Recovery and purification process development for monoclonal antibody production. mAbs. 2010; 2(5): 480– 499. 20647768 PMC2958570
  8. [8]Shukla AA, Hubbard B, Tressel T, Guhan S, Low D Downstream processing of monoclonal antibodies—application of platform approaches. J Chromatogr B. 2007; 848(1): 28– 39. doi: 10.1016/j.jchromb.2006.09.026. 17046339 · DOI
  9. [10]Rathore AS, Bhambure R, Ghare V Process analytical technology (PAT) for biopharmaceutical products. Anal Bioanal Chem. 2010; 398(1): 137– 154. doi: 10.1007/s00216-010-3781-x. 20480150 · DOI
  10. [11]Folta-Stogniew E, Williams K Determination of molecular masses of proteins in solution: implementation of an HPLC size exclusion chromatography and laser light scattering service in a core laboratory. J Biomol Techniques. 1999; 10(2): 51– 63. PMC2291588 19499008
  11. [12]Wyatt PJ Light scattering and the absolute characterization of macromolecules. Anal Chim Acta. 1993; 272(1): 1– 40. doi: 10.1016/0003-2670(93)80373-S. · DOI
  12. [13]Bouvier ESP, Koza SM Advances in size-exclusion separations of proteins and polymers by UHPLC. Trends Anal Chem. 2014; 63:85–94. doi: 10.1016/j.trac.2014.08.002. · DOI
  13. [14]Fekete S, Beck A, Veuthey JL, Guillarme D Theory and practice of size exclusion chromatography for the analysis of protein aggregates. J Pharm Biomed Anal. 2014; 101:161–173. doi: 10.1016/j.jpba.2014.04.011. 24816223 · DOI
  14. [15]Hungenberg KD, Reed WF Online monitoring, control, and optimization of polymer reactions and processes. Macromolecular React Eng. 2017; 11(4). doi: 10.1002/mren.201700030. · DOI
  15. [16]McAfee T, Leonardi N, Montgomery R, Siqueira J, Zekoski T, Drenski MF, Reed WF Automatic control of polymer molecular weight during synthesis. Macromolecules. 2016; 49(19): 7170– 7183. doi: 10.1021/acs.macromol.6b01522. · DOI
  16. [17]Chen J, Tetrault J, Ley A Comparison of standard and new generation hydrophobic interaction chromatography resins in the monoclonal antibody purification process. J Chromatogr A. 2008; 1177(2): 272– 281. doi: 10.1016/j.chroma.2007.07.083. 17709111 · DOI
  17. [18]Yuefeng L, Brian W, Ronald G Recent advancement in application of hydrophobic interaction chromatography for aggregate removal in industrial purification process. Curr Pharm Biotechnol. 2009; 10(4): 427– 433. 19519419
  18. [19]Patel BA, Pinto NDS, Gospodarek A, Kilgore B, Goswami K, Napoli WN, Desai J, Heo JH, Panzera D Pollard D and others. On-line ion exchange liquid chromatography as a process analytical technology for monoclonal antibody characterization in continuous bioprocessing. Anal Chem. 2017; 89(21): 11357– 11365. doi: 10.1021/acs.analchem.7b02228. 28981255 · DOI
  19. [20]Mori S, Barth HG Size exclusion chromatography. Berlin: Springer; 1999.

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Sorted by citations

Authors
Patel, B. A., Gospodarek, A., Larkin, M., Kenrick, S. A., Haverick, M. A., Tugcu, N., Brower, M. A., & Richardson, D. D.
Affiliations
  • Biologics Process Development and Clinical Manufacturing, Merck & Co., Inc., Kenilworth, NJ, USA
  • Wyatt Technology Corporation, Santa Barbara, CA, USA
ORCID
Venue
mAbs
Publisher
Informa UK Limited
Published
2018-08-21
Pages
1-6
ISSN
  • 1942-0862
  • 1942-0870
DOI
10.1080/19420862.2018.1505178
PMC
PMC6204791
Cited by
23
References
0
Language
en

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